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OncoMatch/Clinical Trials/NCT06385418

Fluorouracil Treatment Via Colon for Colorectal Cancer

Is NCT06385418 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Colonic local administration of fluorouracil with enhanced adhesion for colorectal cancer.

Phase 2RecruitingThe Second Hospital of Nanjing Medical UniversityNCT06385418Data as of Jun 2026Location: China

Treatment: Colonic local administration of fluorouracil with enhanced adhesionFluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Colonic local administration of fluorouracil with enhanced adhesion

Cancer type

Colorectal Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 75

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L

Kidney function

Creatinine <120 μmol/L, or MDRD eGFR >60 mL/min

Liver function

Total bilirubin ≤1.5x ULN (≤3x ULN with biliary drainage); ALT and AST ≤5x ULN; for patients with liver metastases, serum total bilirubin ≤3x ULN

Cardiac function

LVEF ≥50% by Doppler echocardiography

Adequate organ function meeting the following criteria: (1) Absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L; (2) Total bilirubin ≤1.5 times the upper limit of normal (patients with biliary drainage via retrograde techniques included); ALT and AST ≤5 times the upper limit of normal, and for patients with liver metastases, serum total bilirubin less than or equal to 3 times the upper limit of the normal reference range; (3) Creatinine <120 μmol/L, or MDRD estimated glomerular filtration rate >60 mL/min; (4) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥50%;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06385418 currently recruiting?

Yes, this trial is currently recruiting patients.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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